The SA Journal Diabetes & Vascular Disease Volume 17 No 1 (July 2020)

RESEARCH ARTICLE

SA JOURNAL OF DIABETES & VASCULAR DISEASE

VOLUME 17 NUMBER 1 • JULY 2020

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Yale study adds to evidence of diabetes drug’s link to heart risk

osiglitazone was associated with a

33% increased risk of a composite

cardiovascular event (heart attack,

heart failure, cardiovascular and non-

cardiovascular related death) compared

with controls, found a Yale analysis of

130 trials involving 48 000 patients.

This study is the most comprehensive

evaluation of the cardiovascular risk of

rosiglitazone ever done. Rosiglitazone

belongs to a class of drugs called

thiazolidinediones. It helps control blood

sugar levels in patients with type 2

diabetes, but it can also increase the risk

of serious heart problems. This has led

to suspension of the drug in Europe and

previous restrictions on its use in the US.

However, since 2007, studies have

reported conflicting findings about

whether rosiglitazone increases the risk

of heart attacks. But these studies didn’t

have access to the raw data, also known

as individual patient-level data (IPD),

from clinical trials and mostly relied on

summary-level data (results reported in

publications and clinical trial registries),

which are not as reliable when estimating

the true safety profile of drugs.

Recent efforts by GlaxoSmithKline

(GSK), the maker of rosiglitazone, to make

IPD available to external investigators

prompted a team of US researchers

at Yale School of Public Health and

the Yale-New Haven Health System to

re-analyse the data and clarify some of

the uncertainties about rosiglitazone’s

cardiovascular risk. They analysed the

results of more than 130 trials involving

over 48 000 adult patients that compared

rosiglitazone with any control for at least

24 weeks. IPD were available for 33 trials,

which included 21 156 patients; the

remaining trials had only summary-level

data available.

When the researchers analysed the

IPD from trials made available by GSK,

they found rosiglitazone was associated

with a 33% increased risk of a composite

cardiovascular event (heart attack,

heart failure, cardiovascular and non-

cardiovascular related death) compared

with controls. This was estimated from the

274 events among 11 837 rosiglitazone

patients and 219 events among 9 319

control patients.

When examining cardiovascular events

independently, the analyses of the 33

GSK trials with IPD resulted in higher

estimates of the risk of heart attacks

than the analyses of trials with IPD and

summary-level data.

‘These findings highlight the potential

for different results derived from different

data sources, and demonstrate the need

for greater clinical trial transparency and

data sharing to accurately assess the

safety of drugs,’ say the researchers.

‘Our study suggests that when

evaluating drug safety and performing

meta-analyses focused on safety, IPD

might be necessary to accurately classify

all adverse events,’ they write. ‘By

including these data in research, patients,

clinicians and researchers would be able

to make more informed decisions about

the safety of interventions.’

They add: ‘Our study highlights the

need for independent evidence assessment

to promote transparency and ensure

confidence in approved therapeutics,

and post-market surveillance that tracks

known and unknown risks and benefits.’

Source: Medical Brief 2020